Articles

A key hurdle for any drug development program is bringing the drug to clinical studies. Astute companies strategize past this milestone and plan for clinical and regulatory success.  
Lack of preparation for scale-up activities needed for eventual commercialization can 	often cause major time delays, increased costs, and a significant amount of rework. This 	eBook provides insights on key approaches and considerations for preparing your 			program for long-term success.


CMC Considerations for Successful Early Drug Development (Mar 2023)

Advances in in silico and experimental techniques mean that APIs and prototype formulations can be thoroughly characterised using multiple material sparing assays, allowing the most promising formulation candidates to move on to in vivo studies.

Developing Optimized Formulations with Minimal Drug Substance

Thousands of drug candidates are abandoned annually due to solubility and bioavailability issues, but advanced formulation technologies can profoundly impact how a drug compound is processed in the body and improve the fate of many of these candidates, improving pharmacokinetic profiles and pharmacodynamic responses. Two Catalent experts discuss the ways companies can address issues with low bioavailability, and the benefits of enlisting an experienced drug development partner.

Partnering for Success: Strategies to Mitigate Common Pitfalls in Early Drug Development

API-sparing development techniques and identification of the appropriate scalable formulation technology to improve drug solubility and enhance oral bioavailability can help increase your chances of success when moving from preclinical development to early phase clinical trials.

Developing Optimal Formulations Using Biorelevant Predictive Tools and Advanced Bioavailability Enhancement Technologies (Mar 2023)

Timely progression of a drug candidate into clinical trials is critical for pharmaceutical companies seeking to bring new products to the market. Streamlining chemistry, manufacturing, and controls (CMC) development can help accelerate this process, as well as help yield better success as the drug product moves through the early phase of clinical studies.


Optimizing the Path from Pre-Clinical to Clinical Development (Mar 2023)

Developers anxious to move their small molecule to Phase I may not have the time or resources to fully characterize the druggability of their candidate. Issues that could delay or even derail the program may appear in later clinical studies. Catalent has the resources to characterize lead molecules and develop the best pathway to bring them to Phase I studies and beyond.

Strategies for De-risking Early-Phase Oral Small Molecule Drug Development

In this report, we will highlight the trends shaping the orphan-drug market, with a particular focus on expedited drug development. Expert insights on navigating development and manufacturing challenges with orphan drugs will be included, with insights on how drug sponsors of all sizes work with contract development and manufacturing organizations (CDMOs) to achieve their goals.

The Future of Orphan Drugs- Insights on the Current Market, Trends & Strategic Partnerships Driving Innovation

The development of orally administered small molecules is becoming more challenging as an increasing number of molecules in pipelines have poor aqueous solubility and bioavailability.

From Candidate to Clinic: Strategies to Accelerate Your Molecule's Development Path 

Lipid formulation and spray-dried dispersions are widely used, and proven technologies to overcome bioavailability challenges for poorly soluble molecules.  For selecting the most suitable formulation technologies in early-phase development, formulation scientists regard efficacy, safety, bioavailability and stability as their top priorities.  However, an early-phase formulation strategy should also consider scale-up and manufacturing challenges that may arise later in development.  If bioavailability and manufacturing challenges are not addressed in early development, the cost and overall timeline of the project may be negatively impacted.  Therefore, developing a bioavailable formulation that is easy to scale-up with superior dose uniformity is imperative for a product’s success.

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